This morning biopharmaceutical company Intra-Cellular Therapies Inc. (ITCI:NASDAQ), which is focused on the development of therapeutics for central nervous system (CNS) disorders, announced "positive topline results from its Phase 3 clinical trial (Study 402) evaluating lumateperone as adjunctive therapy to lithium or valproate in the treatment of major depressive episodes associated with Bipolar I or Bipolar II disorder."
The firm stated that in the Phase 3 Study 402, once daily lumateperone 42 mg successfully achieved the primary endpoint for improvement in depression as measured by change from baseline versus placebo on the MADRS total score, and it additionally met the study's secondary endpoint, the CGI-BP-S Depression Score. The company indicated that lumateperone demonstrated a favorable safety profile and was generally well tolerated in the trial.
The company noted that the data from this trial together with the results of its previously reported positive Phase 3 monotherapy study, Study 404, will form the basis for its Supplemental New Drug Application (sNDA) for the treatment of bipolar depression in patients with Bipolar I or II disorder as monotherapy and adjunctive therapy. The firm advised that it expects that it will submit the sNDA to the U.S. Food and Drug Administration (FDA) in late 2020 or early 2021.
The company's Chair and CEO Dr. Sharon Mates commented, "Our program now has confirmatory evidence of efficacy and a favorable safety and tolerability profile of lumateperone in bipolar depression; we look forward to submitting our supplemental NDA to expand lumateperone's label to include a second major neuropsychiatric disorder...With this clinical milestone, lumateperone has shown further potential to benefit patients suffering from a range of serious mental health conditions in addition to schizophrenia."
Dr. Roger McIntyre, professor of psychiatry and pharmacology at the University of Toronto and head of the Mood Disorders Psychopharmacology Unit at the University Health Network, Toronto, remarked, "Bipolar disorders are serious and complex mental health conditions that affect millions of people, and depression is the most common presentation of these disorders. In this study, lumateperone demonstrated a robust effect, which is particularly significant considering patients were maintained on lithium or valproate...Lumateperone is the first treatment to demonstrate efficacy for bipolar depression as monotherapy and as adjunctive therapy to mood stabilizers in a study population including both Bipolar I and Bipolar II patients. This will be welcome news to the psychiatric community as there is a tremendous need for improved treatment options."
The company noted that its Phase 3 Study 402 took place in the U.S. and four other countries and included 529 patients with moderate to severe major depressive episodes associated with either Bipolar I or Bipolar II disorder. Patients in the study were maintained on lithium or valproate as mood stabilizers and were randomized equally to either lumateperone 42 mg, 28 mg or placebo. The firm noted that the results showed that 42 mg dose of lumateperone met both the primary and secondary endpoints versus placebo at week 6 measured by change from baseline on the MADRS total score and the improvement on the CGI-BP-S Depression Score. Lumateperone 28 mg also displayed a trend for a dose-related improvement in symptoms of depression, but it was not formally tested against placebo though it did demonstrate a statistically significant improvement versus placebo on the CGI-BP-S Depression Score.
The company explained that "pharmacodynamics studies have shown lumateperone acts as a potent antagonist with high binding affinity at serotonin 5-HT2A receptors." The firm added that "these receptors are believed to play an important role in schizophrenia, bipolar disorder, depressive disorders and other neuropsychiatric disorders."
The company stated that lumateperone is presently being investigated for use in the treatment of bipolar depression, depression and other neuropsychiatric and neurological disorders, but has not yet been approved by FDA for these disorders. The firm's CAPLYTA 42 mg (lumateperone) has already been approved by the FDA for use in treatment of adult schizophrenia.
The firm explained that Bipolar I and Bipolar II disorders are highly prevalent serious psychiatric conditions that effect approximately 6 million adults in the U.S. Bipolar I & II disorders occur nearly equally in patients suffering with bipolar disorders with symptoms that typically include recurrent episodes of mania or hypomania intermixed with episodes of serious depression, which is commonly referred to as Bipolar depression. The company advised that Bipolar depression episodes usually tend to recur more often, last longer and are associated with a worse prognosis than the manic or hypomanic episodes.
Intra-Cellular Therapies is a biopharmaceutical company headquartered in New York that focuses on understanding of how therapies affect the inner-workings of cells in the body. The company states it employs this intracellular approach to develop innovative treatments for people living with complex psychiatric and neurologic diseases to help reduce the burden on patients and their caregivers.
Intra-Cellular Therapies started the day with a market capitalization of around $1.2 billion with approximately 67.31 million shares outstanding and a short interest of about 7.4%. ITCI shares opened nearly 70% higher today at $31.10 (+$12.67, +68.75%) over yesterday's $18.43 closing price. The stock has traded today between $27.87 and $33.74 per share and is currently trading at $32.57 (+$14.14, +76.72%).[NLINSERT]
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